Status:
TERMINATED
Frequent, Low-Dose Erythropoietin A Mechanistic Approach to Mitigate Adverse Cardiovascular Effects of Erythropoietin
Lead Sponsor:
VA Office of Research and Development
Conditions:
Anemia
CKD
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Although several large well designed clinical trials have shown that erythropoietin which is commonly used to treat anemia associated with kidney disease, increases the risk of stroke and heart diseas...
Detailed Description
Erythropoietin (EPO) is the most widely prescribed cytokine, yet the benefits and potential side effects of different dosing regimens are poorly understood. It is now recognized that erythropoietin ad...
Eligibility Criteria
Inclusion
- The investigators will enroll Veterans who fulfill the following criteria:
- stage 3, 4, or 5 CKD (estimated glomerular filtration rate of less than 60 ml/min/1.73 m2) on at least two separate occasions greater than 3 months apart; and
- candidates for EPO therapy as per the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative guidelines (hemoglobin \< 10 gm/dL and anemia of CKD).
Exclusion
- The investigators will exclude any Veteran who meets any of the following criteria:
- pregnant, planning to become pregnant in the next year, or breast feeding;
- uncontrolled hypertension (blood pressure \> 180/100 mm Hg despite optimal antihypertensive medications);
- active gastrointestinal bleeding (visible blood or positive tests for stool occult blood accompanied by a decrease in hemoglobin);
- likely to have EPO resistance;
- an adverse cardiovascular event in the prior three months;
- active or recent (within the last 3 months) severe, systemic infection;
- active inflammatory disease such as lupus, rheumatoid arthritis, or vasculitis requiring immunosuppressive or immunomodulatory medications;
- history of solid organ transplantation;
- expected off-dialysis survival of less than one year (as determined by the estimated glomerular filtration slope and the treating physician;
- active cancer (undergoing chemotherapy or radiation within the last 3 months) or primary bone marrow disease such as myelofibrosis; or
- a contraindication for an MRI or individuals who cannot comply with the study protocol. The investigators will exclude healthy subjects that meet a, b, f, g, h, or j.
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03277183
Start Date
November 2 2017
End Date
June 3 2019
Last Update
August 13 2020
Active Locations (1)
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1
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608